FDA Adverse Event Other Summary report: N

PALIND 19/36 SLOT KIT W/VT

MDR report key: 1023778 · Received March 20, 2008

Report

Report Number
1317749-2008-00051
Event Type
Other
Date Received
March 20, 2008
Date of Event
February 28, 2008
Report Date
February 29, 2008
Manufacturer
TYCO HEALTHCARE/KENDALL
Product Code
MPB
Product Problem
Yes
Report Source
Manufacturer report
Reporter Location
NY, US
Reporter Occupation
OTHER

Narratives

Additional Manufacturer Narrative · 1

AN INVESTIGATION IS CURRENTLY UNDER WAY. UPON COMPLETION, THE RESULTS WILL BE FORWARDED.

Description of Event or Problem · 1

IT WAS REPORTED TO TYCO HEALTH CARE/KENDALL IN 2008 THAT A CUSTOMER HAD A PROBLEM WITH A DIALYSIS CATHETER. CUSTOMER REPORTED: "BLUE ADAPTER CRACKED AND CATHETER HAD TO BE REPLACED."

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1 PALIND 19/36 SLOT KIT W/VT DIALYSIS CATHETER MPB TYCO HEALTHCARE/KENDALL 8888145039 728948

Patients

Seq Age Sex Outcome Treatment
1 UNK